Entries by PharmOut

PDA suggest "Code of Conduct" for Data Integrity

Data Integrity
The Parenteral Drug Association (PDA) recently released a free “Points to Consider” document to members that outlines a number of key elements that would make up a “Code of Conduct” for Data Integrity …

overcoming regulatory hurdles

Project bites from in the trenches

A day in a PharmOut consultant’s life
I’m often asked what a typical PharmOut day entails. After recently hearing from one of our consultant’s partners, that they were completely amazed when he told her what …


EU releases Annex 15 validation and qualification

On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.